藥物洗脫冠脈支架現(xiàn)狀和發(fā)展趨勢(shì).

1、藥物洗脫冠脈支架現(xiàn)狀和發(fā)展趨勢(shì)藥物洗脫冠脈支架現(xiàn)狀和發(fā)展趨勢(shì) 蒲忠杰蒲忠杰 Ph.D.Ph.D.樂普（北京）醫(yī)療器械股份有限公司樂普（北京）醫(yī)療器械股份有限公司目目 錄錄 藥物支架的現(xiàn)狀藥物支架的現(xiàn)狀 存在的安全性問題存在的安全性問題 解決的可能途徑解決的可能途徑 降低高分子載體的安全性風(fēng)險(xiǎn)降低高分子載體的安全性風(fēng)險(xiǎn) 發(fā)展完全可降解支架發(fā)展完全可降解支架 優(yōu)化血小板治療優(yōu)化血小板治療 發(fā)展趨勢(shì)發(fā)展趨勢(shì)國產(chǎn)藥物支架國產(chǎn)藥物支架 微創(chuàng)：微創(chuàng)： 樂普：樂普： 吉威：吉威： 垠億：垠億：FirebirdFirebird PartnerNano (R&D)Excel紫杉醇支架紫杉醇支架Backg

2、round: breakthrough technologiesDriver of restenosisrecoilneointima formationimplantation techniquemechanical stabilization of acute resultlocal delivery of anti-proliferative agents5%BMSPTCADESNeed for revascularization40%20%fool-proof delivery system ?藥物支架的現(xiàn)狀藥物支架的現(xiàn)狀基本解決了再狹窄的問題基本解決了再狹窄的問題 結(jié)束了二十年來介入

3、器械與再狹窄作斗爭(zhēng)的結(jié)束了二十年來介入器械與再狹窄作斗爭(zhēng)的歷史歷史存在遠(yuǎn)期血栓的安全性風(fēng)險(xiǎn)存在遠(yuǎn)期血栓的安全性風(fēng)險(xiǎn)技術(shù)變革解決臨床問題技術(shù)變革解決臨床問題安全性問題安全性問題再狹窄問題再狹窄問題BMSPESSESBMSConclusions:BMS showed far greater endothelialization than DESLack of coverage highlighted in areas of overlapLess surface coverage by endothelial cells in PES than SESDelayed endothelializat

4、ionFinn et al. Circulation. 2005;112:270-278.內(nèi)皮化延遲是問題的核心內(nèi)皮化延遲是問題的核心 缺乏系統(tǒng)性的基礎(chǔ)研究：缺乏系統(tǒng)性的基礎(chǔ)研究： 未明確延遲內(nèi)皮化的關(guān)鍵因素（藥物、載體、未明確延遲內(nèi)皮化的關(guān)鍵因素（藥物、載體、交互作用）交互作用） 促進(jìn)內(nèi)皮化的可能途徑促進(jìn)內(nèi)皮化的可能途徑 減少與藥物支架相關(guān)的安全因素和促進(jìn)內(nèi)皮減少與藥物支架相關(guān)的安全因素和促進(jìn)內(nèi)皮化的途徑如何接合化的途徑如何接合解決遠(yuǎn)期血栓的途徑解決遠(yuǎn)期血栓的途徑 支架設(shè)計(jì)支架設(shè)計(jì) 藥物：有效成分藥物：有效成分 高分子載體：非絕對(duì)有效成分高分子載體：非絕對(duì)有效成分 支架平臺(tái)：無直接關(guān)聯(lián)支架平

5、臺(tái)：無直接關(guān)聯(lián)新一代藥物支架的發(fā)展方向新一代藥物支架的發(fā)展方向 減少高分子載體的有害作用減少高分子載體的有害作用 發(fā)展完全可降解支架發(fā)展完全可降解支架Directional Drug Delivery (ablumenal preference) Selective coating on the outside surface of the stent Reduced drug/polymer Lumenal surface BMS Drug only where neededLabcoat JACoating TechnologyBiodegradable Drug/Carrier:Biol

6、imus A9 / Poly (Lactic Acid) 50:50 mixabluminal surface only (contacts vessel wall)15 meter coating thicknessdegrades in 9 months releasing CO2+ waterStent Platform: stainless steel (112 m) corrugated ring, quadrature-link designradius link enhances axial fatigue lifeParylene Durable Primer Coating:

7、5 meter thick, encapsulates stentprevents surface metal ion migrationbiostable + athrombogenic*BioMatrix II Stent Platform DesignBIOFLEX IBioFlex I stent* Data per NHLBI sponsored study, available from BSIConor Drug Release Technology Drug ReservoirLuminalBarrier LayerSimple Drug ReservoirUniform Re

8、leaseSingleDrugStructureMultipleDrugStructuresDrug A releasedto arterial wallBarrier layerDrug B releasedinto bloodstreamTwo Drugs, One WellTwo Drugs, Two WellsTwo DirectionsLuminal BarrierMural BarrierMural SideA Completely Polymer-Free StrategyTranslumina YUKON ChoiceDES Polymer-free coating Uniqu

9、e roughened surface Adjustable dosage for individualized treatment Free choice of drugsMIV Polymer-free DES樂樂 普普 公公 司司Nano無載體藥物洗脫支架無載體藥物洗脫支架 納米微孔載藥納米微孔載藥載藥后，支架表面載藥后，支架表面均勻一致均勻一致Results from Nano FIM clinical study: LL at 6-8 MonthsNanoTMPartnerTMl與裸金屬支架相同的安全性，與藥物支架相同的有效性與裸金屬支架相同的安全性，與藥物支架相同的有效性0.370

10、.260.340.30Design Principle of EPC Capturing and Drug Eluting Combination StentEPC Capturing and Drug Eluting Combination Stent外表面已噴涂雷帕霉素外表面已噴涂雷帕霉素Inner surface-CD34 antibodyOuter surface-RapamycinRAPAMYCINAdsorption principal of CD34 antibody on the stents surfacePorous adsorptionCharge adsorptionY

11、YYYY YYCD34 antibody coatingPatents：PCT/CN2007/002964The activity of CD34 antibody of the inner surface The inner surface of BMSImmerse in KG-1a cell suspension stained by DAPI (CD34+ Cell,ATCC) BMSCombination stentThe inner surface of Combination stentPhoto by microscopeEndothelium Appraisement EM Morphology on the 7th dayBMS CD34 stent Combination stentAnimal Experimental Results in porcine-QCA0.000.050.100.150.200.250.30BMSCD34 stentCombination stentLateLOss（mm）Late Loss at 28 DayP0.05REVA Bioresorbable Coronary Stent發(fā)展趨勢(shì)發(fā)展趨勢(shì)新新一代一代藥物藥物支架支架將在將在保證保證有效有效性的性的基礎(chǔ)基礎(chǔ)上上著著重重解決解決安全安全性性問題問題。減少減少高高